Patient interface with forehead support system

ABSTRACT

A patient interface having a forehead support adjustably. The forehead support assembly includes a support arm that is adjustably mounted to the mask shell, thereby allowing the adjustment of the distance between the forehead support bracket and the mask shell in order to adjust for patient&#39;s of different sizes. A forehead support bracket is pivotally connected to the support arm. The pivoting forehead support bracket is self-aligning to allow the forehead pad to remain parallel to the patient&#39;s forehead at all times, thus enhancing comfort and stability. The forehead support bracket is removable from the support arm, allowing the headgear (with support bracket attached) to be donned separately from the mask and support arm. The forehead support bracket in one embodiment has a forehead pad formed from the headgear itself.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. § 119(e) fromprovisional U.S. patent application No. 60/408,836 filed Sep. 6, 2002,the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention pertains to a support system for a gasdelivery mask, and, in particular to a forehead support system for a gasdelivery mask and to a system for supplying a flow of gas to a patientthat incorporates such a forehead support system.

[0004] 2. Description of the Related Art

[0005] There are numerous situations where it is necessary or desirableto deliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in their esophagus. For example, it is known to ventilatea patient using a technique known as non-invasive ventilation. It isalso known to deliver continuous positive airway pressure (CPAP) orvariable airway pressure, which varies with the patient's respiratorycycle, to treat a medical disorder, such as sleep apnea syndrome, inparticular, obstructive sleep apnea (OSA), or congestive heart failure.Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support device with the airway of the patient so that a flow ofbreathing gas can be delivered from the pressure/flow generating deviceto the airway of the patient. It is known to maintain such masks on theface of a patient by a headgear having upper and lower straps, eachhaving opposite ends threaded through connecting elements provided onthe opposite sides and top of a mask.

[0006] Because such masks are typically worn for an extended period oftime, it is important the headgear maintain the mask in a tight enoughseal against a patient's face without discomfort. A problem arises inthat in order for the mask to maintain a seal without any undue gasleaks around the periphery of the mask, the mask may be compressedagainst the patient's face.

[0007] It is known to provide forehead supports associated with gasdelivery masks to provide a support mechanism between the mask and thepatient's forehead. Gas delivery masks having forehead cushions, spacersor supports are described in U.S. Pat. Nos. 4,907,584; 5,243,971;5,517,986; 5,570,689;6,119,693 and 6,357,441. The forehead supportsprevent the mask from exerting too much force on a patient's face at onegeneral location by dispersing the load over a larger area, providesgreater control of the force on the patient at certain pressure points,such as at the bridge of the nose, and provides stability to the mask.

[0008] Another mask with forehead support is disclosed in InternationalPublication No. WO/78384 A1. In this arrangement a forehead support isadapted to be secured to a respiratory mask. The forehead supportincludes a joining member for securing to the mask and a cushion framepivotally mounted to the joining member. While pivotal movement of thecushion frame to the joining member in one dimension allows the positionof the forehead cushions to be adjusted, it does not optimize the rangesof positions for the forehead on a human head.

[0009] From the above-identified conventional masks, it can beappreciated that an advantage exists for increased stability of the gasdelivery mask support. Another advantage exists for a forehead supportthat evenly distributes headgear strapping force. A further advantageexists for a mask that has an adjustable forehead support adaptable to awide range of forehead configurations and sizes. Still yet, a furtheradvantage exists for a forehead support bracket that allows the headgearand mask to be donned separately.

SUMMARY OF THE INVENTION

[0010] An exemplary embodiment of the present invention comprises apatient interface gas delivery mask having a forehead support includingan adjustably mounted support arm and a forehead support bracket, and toa system for supplying a flow of gas to a patient that incorporates sucha mask and forehead support.

[0011] An exemplary embodiment of the present invention provides aforehead support that includes a support arm adjustably mounted to themask shell, thereby providing adjustment along an axis or curve which isnormal to the plane of the mask shell to adjust for patients ofdifferent sizes and shapes. The adjustment assembly allows a patient toadjust the mask in such a way as to minimize leakage and pressure oncertain areas of the face, such as the nose bridge.

[0012] An exemplary embodiment of the present invention includes aforehead support bracket which is slideably connected to the supportarm. The forehead support bracket is self-aligning so that it allows theforehead pad to remain parallel to the patient's forehead at all times,thus enhancing comfort and stability. In an exemplary embodiment of thepresent invention, the forehead support bracket is removable from thesupport arm, allowing the headgear (with forehead support bracketattached) to be donned separately from the mask and support arm. Thisallows the patient to easily remove the mask without having to removethe headgear straps. An exemplary embodiment of the present inventionfurther comprises a forehead support bracket having a forehead padformed from the headgear itself.

[0013] These features and characteristics of the present invention, aswell as the methods of operation and functions of the related elementsof structure and the combination of parts and economies of manufacture,will become more apparent upon consideration of the followingdescription and the appended claims with reference to the accompanyingdrawings, all of which form a part of this specification, wherein likereference numerals designate corresponding parts in the various figures.It is to be expressly understood only and not intended as a definitionof the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014]FIG. 1 is a perspective view of the mask and forehead supportsystem according to the principles of an exemplary embodiment of thepresent invention shown (schematically) connected to a gas flowgenerating device;

[0015]FIG. 2 is a partial side of the mask and forehead support systemof FIG. 1;

[0016]FIG. 3 is an exploded view of the mask and forehead support systemof FIG. 1;

[0017]FIG. 4 is a partial perspective of a second embodiment of a maskand forehead support system according to the present invention;

[0018]FIG. 5 is a partial perspective view of a third embodiment of amask and forehead support system according to the present invention;

[0019]FIG. 6 is a partial perspective of a fourth embodiment of a maskand forehead support system according to the present invention;

[0020]FIG. 7 is a partial perspective view of a fifth embodiment of amask and forehead support system according to the present invention;

[0021]FIG. 8 is a partial side view of the mask and forehead supportsystem of FIG. 7;

[0022]FIG. 9 is a perspective view of the support arm of FIG. 7;

[0023]FIG. 10 is a bottom perspective view of the slide pin of FIG. 7;

[0024]FIG. 11 is a top view of the forehead support bracket of FIG. 7with the addition of a headgear strap; and

[0025]FIG. 12 is a back view of the forehead support bracket of FIG. 7with the headgear strap.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS OF THEINVENTION

[0026] In describing the presently preferred embodiments of theinvention, the terms “horizontal ” and “vertical” refer to theorientation of the mask as illustrated in the accompanying drawings.

[0027] FIGS. 1-3 illustrate an exemplary embodiment of a gas deliverymask 10 according to the principles to the present invention. Gasdelivery mask 10 functions as a patient interface device to communicatea flow of breathing gas between a patient's airway and a pressuregenerating device 12, such as a ventilator, CPAP device, autotitratingCPAP device, PPAP, PAV®, or variable pressure device, e.g. a BiPAP®device manufactured and distributed by Respironics, Inc. of Pittsburgh,Pa., in which the pressure provided to the patient varies with thepatient's respiratory cycle so that a higher pressure is deliveredduring inspiration than during expiration.

[0028] Referring to FIGS. 1-3, there is illustrated a gas delivery mask10 including a mask shell 14 or body portion which is preferably, butnot necessarily, a generally rigid, formed structural shell having anopen side that defines an annular portion 16 to which a resilient,relatively soft cushion or seal member 18 is attached. In theillustrated exemplary embodiment, mask shell 14 is substantiallytriangular in shape, having an upper apex angle 20 and two lower angles22. Mask shell 14 includes an inlet opening 24 adapted to receive a gassupply conduit 26. Mask shell is preferably formed from rigid plastic,such as Polycarbonate. Seal member 18 is configured to receive a portionof the patient, such as the nose. Alternatively, mask 10 may, instead,comprise a nasal/oral mask configured to enclose the nose and mouth of apatient or an oral mask configured to enclose only the mouth of apatient.

[0029] In the illustrated exemplary embodiment, a lower headgearconnector assembly 28 includes a pair of first connectors 30 rigidlyattached to lower angles 22 of mask shell 14. Lower headgear straps inheadgear assembly are selectively connected to mask 10 by means of asecond connector 32. In the illustrated embodiment, a pair of secondconnectors 32, are removably connectable to end portions of headgearstraps (not shown) and are also removably connectable to firstconnectors 30 on each side of mask shell 14. Alternately, lower headgearconnector assembly 28 can be any suitable headgear connector assembly.

[0030] Likewise, the present invention contemplates the headgear can beany suitable headgear, i.e., and conventional headgear used in thepatient interface field. For example, a typical headgear assemblycomprises a headpiece (not shown) that overlies a portion of thepatient's crania and with a pair of lower headgear straps and a pair ofupper headgear straps extending therefrom to adjustably connect theheadgear to the mask.

[0031] A forehead support 34, according to the illustrated exemplaryembodiment, is provided at upper apex angle 20. Forehead support 34 inthis embodiment is generally T-shaped and includes a support arm 36which is connected at its upper end 38 to a horizontal forehead supportbracket 40. Forehead support bracket 40 includes a forehead pad 42 onthe patient contacting side.

[0032] Forehead pad 42 forms the actual contact point of foreheadsupport bracket 40 to the forehead of the patient and is formed from anelastomeric cushioning material, such as silicon. In the illustratedembodiment, forehead pad 42 is rectangular in shape formed from a firstwall 43 that contacts the patient and a second wall 44 havingprotrusions 46 that are connectable to respective openings (notillustrated) on forehead support bracket 40. A gap is provided betweenthe first wall and the second wall so that the first wall moves towardthe second wall when the mask is donned by a user and as the force onthe forehead pad increases. A pair of retaining walls 48 extendingbetween the first and second walls (43, 44) provide stability, forexample, so that the first wall does not readily collapse onto thesecond wall as the force on forehead pad increases. The presentinvention contemplates that forehead pad 42 can be any suitablecushioning element and may include more than one pad and/or differentsizes or variations or formed from alternative materials, such as gel,foam, or silicone.

[0033] The present invention further includes an adjustment assembly 50in order to provide adjustment of the forehead support along an axis orcurve, which is generally normal to the plane of mask shell 14.Adjustment assembly 50 allows the user to control the position of theforehead support, so that a common mask can be properly fitted topatients of different sizes and shapes. Moreover, adjustment assembly 50allows a patient to adjust the mask in such a way as to minimize leakageand pressure on certain areas of the face, such as the nose bridge.

[0034] Adjustment assembly 50 is defined by components provided on maskshell 14 and a lower end 52 of support arm 36 so that support arm 36 isadjustably connectable to mask shell 14. More specifically, adjustmentassembly 50 includes an arcuate attaching member 54 disposed on maskshell 14 and extending from a central portion of the mask shell aboveinlet opening 24 to a position spaced above upper apex angle 20 of maskshell 14. Attaching member 54 preferably is in the form of a track andincludes multiple pairs of opposed teeth 56 (FIG. 3), where each tooth56 extends in a horizontal direction. Adjustment assembly 50 alsopreferably includes two spaced apart flexible members 58 provided at thelower end of the support arm, where each flexible member 58 has a hookportion 60 at its distal end. It is to be understood, however, that asingle row of teeth and a single flexible member corresponding therewithare also contemplated by the present invention.

[0035] When support arm 36 is connected to mask shell 14, attachingmember 54 is received within support arm 36 with hook portions 60 offlexible members 58 engaging a pair of opposed teeth 56, thus lockingsupport arm 36 into position relative to mask shell 14. Pressingflexible members 58 inwardly, as indicated by arrows A in FIG. 1, allowshook portions 60 to release from teeth 56 in order to change position toanother set of opposed teeth 56 or in order to release support arm 36and, thus, forehead support 34 from the mask shell entirely. Foreheadsupport 34 is detachable from the mask shell 14 for cleaning orreplacement. The present invention contemplates that any number ofopposed teeth could be used. In addition, the teeth could be on thesupport arm and the hook portions could be on the attaching member.

[0036] It can appreciated from the above description and theaccompanying illustrations, that the adjustment assembly of the presentinvention allows the forehead support, including the support arm,forehead support bracket and forehead pad, to move relative to the maskshell in two general directions simultaneously. First, the entireforehead support moves in a generally vertical direction, i.e., in adirection parallel to the plane in which the mask shell lies, asindicated by arrow B in FIG. 2, to move the forehead pad closer to oraway from the mask shell. Second, the entire forehead support moves in agenerally horizontal direction, i.e., in a direction generallyperpendicular to the plane in which the mask shell lies, as indicated byarrow C in FIG. 2, to adjust the distance of the forehead support andthe patient.

[0037] This simultaneous, two dimensional movement, which is indicatedby arrow D in FIG. 2, is made possible by the curvilinear shape of theadjustment assembly, and, more particularly, the curvilinear shape ofattaching member 54. This feature of the present invention allows theforehead support to be adjusted for the optimal, i.e., most comfortable,fit on the patient. In addition, the curvilinear movement of theforehead support allow the positioning of the forehead support to betterapproximate the shape of the human forehead than conventional foreheadsupports, which provide only pivoting movement about a fixed pivot pointor linear movement along a single axis, e.g., along an axis correspondto arrow C in FIG. 2.

[0038] As best seen in FIG. 3, upper end 38 of support arm 36 isgenerally bifurcated forming two parallel vertical walls 62. A tongue 64is perpendicularly and rigidly connected to the inside edge of eachwall. Forehead support bracket 40 includes a pair of grooves 65 ortracks (one of which is shown in FIG. 3) extending in an arched shapeand corresponding to tongues 64 for sliding receipt of the tongues.Movement of tongues 64 along grooves 65 causes the forehead supportbracket 40 to move relative to the support arm 36 along a curvilinear orarc-shaped path, as indicated by arrow E in FIG. 2. It can beappreciated that the axis of rotation for the embodiment shown in FIGS.1-3 is located at the centerpoint of the concentric circles that definearched grooves 65, which would be a virtual axis located a distance fromthe forehead support bracket. In this manner, the moveable attachment ofthe support art to the support bracket provides a connecting assemblythat enhances automatic positioning of the forehead support on thepatient.

[0039] Because this virtual centerpoint is actually located off of thesupport arm and the forehead support bracket, and, more particularly,below the surface of the patient's skin when wearing the mask, itprovides self-alignment while creating a condition of high stability.The design of this virtual pivot is intended to reduce the likelihood ofthe forehead support bracket 40 tipping at an undesirable angle relativeto the patient's skin when the mask is donned. In this way, the foreheadsupport bracket 40 is self aligning to conform to the shape of thepatient's head.

[0040] Forehead support bracket 40 is also detachable from support arm36 by pressing a center tab 66 on forehead support bracket 40 andsqueezing each of the two parallel vertical walls 62 on the upper end ofthe support arm. This allows detachment of the headgear for cleaningpurposes or to allow a patient to don the headgear (with foreheadsupport bracket 40 attached) and then attach support arm 36 to foreheadsupport bracket 40. This also allows a patient to leave headgear straps68 attached to the forehead support bracket at a desirable length whendoffing and donning the mask so that the optimum headgear strapadjustment does not have to occur every time.

[0041] Each end portion 70 of the forehead support bracket, preferablyincludes a connector element 72 for securing an upper headgear strap 68.In this preferred embodiment, the connector element 72 is a femalereceiving slot for receiving a male quick release element 74 attached toan upper headgear strap 68. However, it should be apparent that otherconnection mechanisms could be used.

[0042] Alternative exemplary embodiments are illustrated in FIGS. 4-10.In these embodiments, many features are similar to those illustrated inFIGS. 1-3. Like reference numerals to those used in describing oneembodiment will be used to denote like features in relation to otherembodiments. It should be noted that the lower portion of the mask shelland lower headgear connector elements are not shown in these figures,because the relevant features can be garnered from reference to FIGS. 1and 3.

[0043] FIGS. 4-6 illustrate alternative embodiments for the adjustmentassembly for the support arm of the forehead support. In a secondembodiment illustrated in FIG. 4, adjustment assembly 50′ of the presentinvention includes forming support arm 36′ into two portions: a shellportion 76 connected to mask shell 14′, and a bracket portion 78connected to forehead support bracket 40′. The portions are connected toeach other using a ratchet-type connection. Shell portion 76 has agenerally tubular cross section having an exterior guide slot 80 havingopposed ratchet-like teeth 82. The bracket portion 78 also has agenerally tubular cross section adapted to slide within the shellportion 76 and having a central protrusion 84 corresponding to the guideslot 80. It is to be understood, however, that the present inventioncontemplates reversing the orientation of the tubular shell portion andthe bracket portion, so that shell portion with the tubular slot isprovided on the forehead support and the bracket portion that slideswithin a tubular slot is provided on the mask shell.

[0044] Like in the second embodiment of FIG. 4, the third embodimentillustrated in FIG. 5 includes an adjustment assembly 50″ having asupport arm 36″ formed into two portions: a shell portion 76′ connectedto mask shell 14″, and a bracket portion 78′ connected to the foreheadsupport bracket 40″. In this embodiment, shell portion 76′ and bracketportion 78′ have generally U-shaped cross sections. The portions areconnected to each other using a ratchet-type connection. Shell portion76′ has guide slots 80′ on each side of its U-shape. Central guide slot80′ has opposed ratchet-like teeth 82′. Bracket portion 78′ also isadapted to slide within shell portion 76′ and has a central protrusion84′ corresponding to central guide slot 80′ along with guide protrusions84′ corresponding to the other two guide slots 80′ (only one of which isshown). In the embodiments of FIGS. 4 and 5, the central protrusions 84,84′ are located on a flexible member (86 shown in FIG. 5) having ratchetteeth (not illustrated) on either side of the central protrusion. Whenthe central protrusion is pressed inwardly, flexible member 86 flexesinwardly allowing the ratchet teeth to disengage from each otter, sothat the shell portion and bracket portion can move relative to eachother. As with the second embodiment, the relative male-femalerelationships between the bracket portion and the shell portion can bereversed.

[0045] Like in the third embodiment of FIG. 5, the fourth embodimentillustrated in FIG. 6 includes an adjustment assembly 50′″ having asupport arm 36′″ formed into two portions: a shell portion 76″ having aU-shaped cross section connected to mask shell 14′″, and a bracketportion 78″ having a U-shaped cross section connected to foreheadsupport bracket 40′″. Shell portion 76″ also includes three guide slots80″ (only two are shown) and the bridge portion 78″ includescorresponding protrusions 84″. However, rather than a system of ratchetteeth for adjustment, the shell portion also includes a pivoting member88, pivotable about its lower end to provide a cam-locking action whenlocked in the position illustrated to supply a frictional force toeffectively lock the relative position of the mask shell 14′″ andforehead support bracket 40′″. This member 88 may be locked at any of aninfinite number of positions within the range of motion, as opposed toother embodiments which have a set number of pre-determined positions.

[0046] In the fifth embodiment illustrated in FIGS. 7-12, the foreheadsupport comprises a support arm 36″″ which is pivotally attached to ahorizontal forehead support bracket 40″″ by means of a coupling systemgenerally indicated at 91. Mask shell 14″″ further includes anadjustment assembly 50″″ adjustably connecting the support arm 36″″ tomask shell 14″″. Mask shell 14″″ includes an arcuate attaching member54′ rigidly attached to and extending from a central portion of maskshell 14″″ above inlet opening 24′ to upper apex 20′. Attaching member54′ includes two concentrically arched ribs 90 forming a slot 92therebetween. The outer curved portion includes a series of horizontalteeth and alternating grooves 94.

[0047] Support arm 36″″ includes a pair of arched engaging elements 96(FIG. 9) that slide within the slot 92 on the attaching member 54′. Alocking assembly 98 is provided to latch support arm 36″″ to attachingmember 54′. In the illustrated embodiment, locking assembly 98 includesa latching slide pin 100, which is retained by support arm 36″″ andwhich slides in a direction perpendicular to the support arm. One ormore teeth and grooves 102 (see FIG. 10) on the slide pin 100 areengageble with the teeth and grooves 94 on the attaching member 54′.Slide pin 100 of the illustrated embodiment is manually engaged but mayalso be spring-loaded.

[0048] As noted above, forehead support bracket 40″″ is pivotallyconnected to the upper end of support arm 36″″ via coupling system 91.In the illustrated embodiment, support arm 36″″ has a generally circularhole 104 formed through its upper end, with a slot 106 cut through aside at a predetermined angle, and forehead support bracket 40″″ has ahorizontally oriented connecting bracket 108 that form the couplingsystem. Connecting bracket 108 has an oblong cross section. The longcross sectional dimension is approximately the same as the hole 104diameter, and the short cross sectional dimensions approximately thesame as the slot width. Connecting bracket 108 may be inserted into slot106 in the support arm 36″″ when the two parts are at a certain angularposition relative to one another. This position is out of the normalrange of use. When forehead support bracket 40″″ is rotated into itsnormal range of use, it is locked in circular hole 104, but free topivot within hole 104 about an axis of rotation 110 (FIG. 9).

[0049] Axis of rotation 110 for the embodiment shown in FIGS. 7-12 isalong the center of the oblong cross-section on the connecting bracket108. When support arm 36″″ and forehead support bracket 40″″ areattached, this coincides with the center of circular hole 104 in theupper end of support arm 36″″. This allows the patient to removeforehead support bracket 40″″ from support arm 36″″ and, thus, the mask,without having to remove the headgear straps from his or her head. Also,the forehead support bracket 40″″ is self aligning, so that it remainsparallel to a patient's forehead regardless of forehead slope, maskposition, or support arm 36″″ position.

[0050] Detachable forehead support bracket 40″″ in the embodiment ofFIGS. 7-12, as well as the embodiment of FIGS. 1-3, allows a patient todon the headgear, with the forehead support bracket attached, separatelyfrom the mask. The mask is rotated to the proper angle forengagement/disengagement and attached to forehead support bracket 40″″.The lower headgear straps are then connected by the use of thedisconnection device provided. To remove the mask, the patientdisconnects the lower headgear straps, rotates the mask to the properangle for engagement/disengagement as indicated by arrow in FIG. 7, andpulls the mask and support arm 36″″ away from forehead support bracket40″″. This leaves the headgear, with forehead support bracket 40″″attached to the headgear, on the patient's head. If the mask were to bereplaced quickly, the patient could choose to leave the headgear andforehead support bracket 40″″ in place, as this would not be asobtrusive as wearing the complete mask assembly. This allows a patientto leave the bedside, get a drink, or other commonly performedactivities without readjusting the headgear, and it would allow quickand easy replacement of the mask when desired.

[0051] As best seen in FIGS. 11 and 12, the present inventioncontemplates that headgear 68′ itself can form the forehead pad.Headgear 68′ passes through openings 112 having retaining rods 114 oneach end of forehead support bracket 40″″. In this embodiment, headgear68′ is arranged across the forehead providing padding and evenlydistributing the strapping force across the forehead.

[0052] The gas delivery mask of all of the embodiments functions as apatient interface device that communicates a flow of breathing gasbetween the patient's airway and pressure generating device, such as aventilator, CPAP device (FIG. 1), or variable pressure device, e.g., aBiPAP® device manufactured and distributed by Respironics, Inc. ofPittsburgh, Pa., in which the pressure provided to the patient varieswith the patient's respiratory cycle so that a higher pressure isdelivered during inspiration than during expiration or anauto-titratition pressure support system where the pressure varies withthe condition of the patient, such as whether the patient is snoring orexperiencing an apnea or hypopnea.

[0053] Communicating a flow of breathing gas between the patient'sairway and a pressure generating device includes delivering a flow ofbreathing gas to the patient from the pressure generating device andexhausting a flow of gas from the patient to ambient atmosphere. Thesystem for delivering a breathing gas to a patient according to thepresent invention comprises a pressure or gas flow generating device 12that produces a flow of gas; a conduit 26 having a first end portionoperatively coupled to the gas flow generating device 12 and a secondend portion, wherein the conduit 26 carries the flow of gas from the gasflow generating device 12 during operation of the system; a gas deliverymask assembly 10 coupled to the second end portion of the conduit; and aheadgear.

[0054] In the illustrated embodiment, the adjustment assembly isconfigured to allow for curvilinear movement of the forehead supportrelative to the mask shell (see, e.g., arrow D in FIG. 2. It is to beunderstood, however, that the present invention contemplates that theadjustment assembly can provided other patterns of translationalmovement of the forehead support relative to the mask shell. Forexample, attaching member 54 can have an “S” shaped pattern, or a “J”shaped pattern so that the forehead support is moveable in an “S” or “J”pattern relative to the mask shell.

[0055] Although the invention has been described in detail for thepurpose of illustration based on what is currently considered to be themost practical and preferred embodiments, it is to be understood thatsuch detail is solely for that purpose and that the invention is notlimited to the disclosed embodiments, but, on the contrary, is intendedto cover modifications and equivalent arrangements that are within thespirit and scope of the appended claims.

What is claimed is:
 1. A gas delivery mask comprising: a mask shell; anda forehead support comprising: a support arm associated with the maskshell, a forehead support bracket, and a connecting assembly couplingthe forehead support bracket to the support arm such that he foreheadsupport bracket is self-aligning on a patient as the mask is donned bysuch a patient.
 2. The mask of claim 1, further comprising an adjustmentassembly for adjusting the relative position of the forehead support andthe mask shell such that the forehead support is moveable in at leasttwo dimensions relative to the mask shell.
 3. The mask of claim 2,wherein the adjustment assembly an includes an arcuate attaching memberassociated with the mask shell, and wherein a first portion of thesupport arm is moveably mounted to the arcuate attaching member.
 4. Themask of claim 3, wherein the adjustment assembly an includes a pluralityof teeth disposed on the arcuate attaching member, and wherein the firstportion of the support arm includes a flexible portion adapted to engageat least one of the plurality of teeth.
 5. The mask of claim 1, whereinthe connecting assembly includes an arcuate track associated with theforehead support bracket and a track engaging member disposed on aportion of the support arm, and wherein the track engaging member isoperatively coupled to the arcuate track so as to move along the arcuatetrack during self-aligning of the forehead support bracket on such apatient.
 6. A gas delivery mask comprising: a mask shell; a foreheadsupport having a support arm associated with the mask shell and aforehead support bracket coupled to the support arm; and an adjustmentassembly for adjusting a relative position of the forehead support andthe mask shell such that the forehead support is moveable in at leasttwo dimensions relative to the mask.
 7. The mask of claim 6, wherein theadjustment assembly an includes an arcuate attaching member associatedwith the mask shell, and wherein a first portion of the support arm ismoveably mounted to the arcuate attaching member.
 8. The mask of claim7, wherein the adjustment assembly an includes a plurality of teethdisposed on the arcuate attaching member, and wherein the first portionof the support arm includes a flexible portion adapted to engage atleast one of the plurality of teeth.
 9. A gas delivery mask comprising:a mask shell; and a forehead support comprising: a support armassociated with the mask shell, a forehead support bracket, and acoupling system attaching the support arm to the forehead supportbracket such that the forehead support bracket is detachable from thesupport arm while the mask is being worn by a patient.
 10. The mask ofclaim 9, further comprising an adjustment assembly for adjusting therelative position of the forehead support and the mask shell such thatthe forehead support is moveable in at least two dimensions relative tothe mask shell.
 11. The mask of claim 10, wherein the adjustmentassembly an includes an arcuate attaching member associated with themask shell, and wherein a first portion of the support arm is moveablymounted to the arcuate attaching member.
 12. The mask of claim 11,wherein the adjustment assembly an includes a plurality of teethdisposed on the arcuate attaching member, and wherein the first portionof the support arm includes a flexible portion adapted to engage atleast one of the plurality of teeth.
 13. The mask of claim 9, whereinthe coupling system includes: a slot defined in a portion of the supportarm; a cut defined in a portion of the support arm extending from theslot at a predetermined angle so as to provide access to the slot; and aconnecting bracket associated with the forehead support bracket, whereinthe connecting bracket is sized and configured to be removeably placedwithin the slot by passing through the cut at the predetermined angle,and wherein the connecting bracket is rotateable within the slotresponsive to being positioned therein.
 14. A forehead support adaptedto be secured to a gas delivery mask, the forehead support comprising: aforehead support bracket; and a connector associated with the foreheadsupport bracket adapted to connect a headgear strap to the foreheadsupport bracket such that the headgear strap spans a length of apatient's forehead to define at least a portion of a cushion between theforehead support bracket and such a patient's forehead.
 15. The foreheadsupport of claim 14, further comprising a headgear strap coupled to theconnector.
 16. A method of donning a gas delivery mask having a maskshell and support arm coupled thereto comprising providing a headgearhaving upper headgear straps, a forehead support bracket coupled to theupper headgear straps, and lower headgear straps; donning the upperheadgear strap on a head of a patient; orienting the gas delivery masksuch that a mash shell is spaced apart from a face of a patient and aforehead support is proximate to the forehead support bracket;connecting the forehead support to the forehead support bracket;rotating the gas delivery mask into place on the face of a patient; andconnecting the lower headgear straps to the gas delivery mask.
 17. Amethod of removing a gas delivery mask from a patient, comprising:disconnecting lower headgear straps of a headgear from the gas deliverymask; rotating the gas delivery mask by moving a mask shell away from aface of a patient while a support arm of the gas delivery mask remainscoupled to a forehead support bracket associated with an upper headgearstrap being worn by such a patient; and disconnecting the support arm ofthe gas delivery mask from the forehead support bracket.